Job Summary
A pharmaceutical and biotechnology development company is seeking a Remote HIV Regulatory Affairs Senior Manager.
Must be able to:
- Critically review documents for submission to regulatory authorities
- Lead the preparation, compilation and the timely filing of regulatory submissions
- Lead cross functional teams in the authoring of regulatory documents
Applicants must meet the following qualifications:
- 8+ years of experience in Regulatory Affairs or other relevant industry experience with BS/BA
- 6+ years of experience in Regulatory Affairs or other relevant industry experience with advanced degree
- Experience as Regional Regulatory Lead managing investigational products and representing Regulatory Affairs
- Must have demonstrated strategic and critical thinking with ability to execute
- Must be capable of reviewing technical documents and influencing colleagues across functions
- Must be capable of effectively leading teams in preparation of submissions
